Jiangsu Cowin Biotech (688426.SH): Clostridium difficile tpi and toxin A, toxin B gene detection kit (fluorescence PCR method) obtained Class III medical device registration certificate.

Jiangsu Cowin Biotech (688426.SH) announced that recently, the Clostridium difficile tpi and toxin A, toxin B gene detection kit (fluorescence PCR method) independently developed by its wholly-owned subsidiary Jiangsu Jianwei Diagnostic Technology Co., Ltd. ("Jianwei Diagnostics") obtained the Class III Medical Device Registration Certificate (In Vitro Diagnostic Reagent) issued by the National Medical Products Administration. The gastrointestinal pathogen detection product "Clostridium difficile tpi and toxin A, toxin B gene detection kit (fluorescence PCR method)" independently developed by Jianwei Diagnostics uses fluorescence PCR technology, targeting the specific sequences of the tpi, tcdA, and tcdB genes in the Clostridioides difficile genome as target regions, and respectively designs specific primers and probes for multiplex PCR amplification and detection. Through the simultaneous detection of the tpi, tcdA, and tcdB genes in stool samples, this product assists in the clinical diagnosis of Clostridium difficile infection.